FDA 510(k)

Abbott gets FDA clearance to bring FreeStyle Libre Pro CGM to US
By Jonah Comstock | 02:19 pm | September 28, 2016
Recent FDA guidances cover software changes, real world evidence, wellness devices
By Jonah Comstock | 05:12 pm | August 09, 2016
Round-up: FDA clearances so far in 2016
By Heather Mack | 08:06 pm | July 21, 2016
Analytica gets over-the-counter FDA clearance for smartphone-connected pelvic floor muscle trainer
By Jonah Comstock | 04:12 pm | July 12, 2016
Nokia Technology gets FDA clearance for Withings Thermo, a WiFi-enabled thermometer
By Jonah Comstock | 03:40 pm | June 29, 2016
FDA clears BioGaming's Microsoft Kinect-based physiotherapy software
By Jonah Comstock | 03:15 pm | February 10, 2016
Viatom gets FDA clearance for Checkme vitals monitoring device
By Aditi Pai | 02:24 pm | December 15, 2015
Philosys gets FDA clearance for glucometer companion Android app
By Aditi Pai | 10:18 am | December 02, 2015
Visible Patient gets FDA clearance for custom 3D anatomy models, app still to come
By Jonah Comstock | 09:50 am | November 17, 2015
NFANT Labs gets FDA nod for smart baby bottle sensors for the NICU
By Jonah Comstock | 12:04 pm | October 12, 2015